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United States· US:53329-033_27d464c8-2b68-5598-e063-6394a90a7ad9

Medline

A piperazine derivatives product containing cetirizine hcl, registered in United States by Medline Industries, LP.

ATC R06AEOrange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedMedlineATCR06AEREGISTER NO.US:53329-033_27d464c8…PACKS LISTED2CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about cetirizine hclAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
cetirizine hcl
Manufacturer
Medline Industries, LP
Country
United States (US)
ATC code
R06AE
ATC class
Piperazine derivatives
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 2

  • ndc11
    5332903333
    30 TABLET in 1 BOTTLE (53329-033-33)
  • ndc11
    5332903338
    90 TABLET in 1 BOTTLE (53329-033-38)

Regulatory notes

UNII (FDA substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A209274
DailyMed SPL labels
1 version tracked

Same class

Other records under R06AE

Piperazine derivatives, as other registers publish it.

All cetirizine hcl products

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/f27485bc-6eb3-4842-8175-6bcbb4a4751b
GET /v1/drugs/f27485bc-6eb3-4842-8175-6bcbb4a4751b?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "unii": {
    "unii": "64O047KTOA",
    "rxcui": "203150",
    "inchikey": "PGLIUCLTXOYQMV-UHFFFAOYSA-N",
    "display_name": "CETIRIZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 3
  },
  "spl_meta": {
    "494d7e97-a3a8-2c7a-e063-6394a90a3ae1": {
      "match": "brand_token",
      "title": "MEDLINE (POVIDONE-IODINE) SWAB [MEDLINE INDUSTRIES, LP]",
      "spl_version": "2",
      "published_date": "2026-04-22"
    }
  },
  "productid": "53329-033_27d464c8-2b68-5598-e063-6394a90a7ad9",
  "productndc": "53329-033",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209274",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Dec 22, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Medline",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209274",
  "marketing_category": "ANDA",
  "nonproprietary_name": "cetirizine hcl",
  "start_marketing_date": "20200501",
  "active_numerator_strength": "10"
}
API referenceMCP serverPlans

See everything about cetirizine hcl.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

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